ACT EU Multi-Stakeholder Platform: Meeting Documents from 18 June 2026
The meeting documents from ACT-EU MSP meeting held on 18 June 2026 are available now on the ACT EU website. These include presentations from the European Commission on Progress with the BioTech Act and specifically its clinical trial related aspects – present by...
Report on the ACT EU Webinar Regarding Contractual Agreements
The report on the ACT EU webinar regarding contractual agreements, held on 16 April, has been published on the ACT EU website. The webinar explored how clinical site agreements affect the start-up of clinical trials and shared national and European experiences on...
Final: ICH E6(R3) GCP Annex 2
π’ ICH E6(R3) GCP Annex 2 was finalized and published by ICH on 3 June 2026. It covers pragmatic and decentralized elements, as well as the use of real-world data (RWD)βtopics frequently discussed in CDDF meetings. The guidance also offers valuable insights into...
[ACT EU Workplan for 2026-2027 β Version 4, May 2026]
The ACT EU workplan for 2026 β 2027 has been adopted by the ACT EU Steering Group and is now published. The workplan reflects the revised ACT EU objectives and takes into account recent legislative and policy developments including the proposed Biotech Act, the...